Holder and deployment system for surgical heart valves

Abstract

A holder for a hybrid heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The hybrid heart valve includes a non-expandable, non-compressible prosthetic valve and a self-expandable anchoring stent, thereby enabling attachment to the annulus without sutures. A first suture connects the holder to the valve and constricts an inflow end of the anchoring stent. A second suture connects the holder to the valve and extends down three holder legs to loop through fabric on the valve. Both sutures may loop over a single cutting well on the holder so that severing the first and second sutures at the single cutting well simultaneously releases the tension in the first suture, permitting the inflow end of the anchoring stent to expand, and disconnects the valve holder from the prosthetic heart valve.

What is claimed is: 
     
       1. A system for delivering a prosthetic heart valve to a native valve annulus, comprising:
 a prosthetic heart valve including a prosthetic valve with valve leaflets mounted to alternately open and close across a flow orifice, and a self-expandable anchoring stent having a contracted state for delivery to an implant position and an expanded state; 
 a valve holder having a central hub with a structure adapted to mate with a delivery handle; 
 at least one connecting suture attaching the valve holder to the prosthetic heart valve at multiple locations and extending around the anchoring stent in tension to constrict the anchoring stent to the contracted state, the at least one connecting suture being routed over a single cutting well on the valve holder such that severing the at least one connecting suture at the single cutting well releases the tension therein and permits the anchoring stent to expand toward its expanded state in contact with the native valve annulus. 
 
     
     
       2. The system of  claim 1 , wherein the prosthetic valve has a fabric-covered non-expandable, non-collapsible annular support structure defining the flow orifice and an inflow end defining an inflow direction with an outflow direction opposite thereto, the valve leaflets being attached to the support structure, and wherein the anchoring stent has a first end extending around the flow orifice connected to the prosthetic valve at the inflow end of the support structure, the anchoring stent having a second end projecting in the inflow direction away from the support structure which transitions between the contracted and expanded states. 
     
     
       3. The system of  claim 2 , wherein the at least one connecting suture includes a first suture extending around the second end of the anchoring stent which when placed under tension constricts the second end to the contracted state. 
     
     
       4. The system of  claim 3 , wherein the at least one connecting suture includes a second suture connecting the valve holder to the prosthetic valve, wherein the first and second sutures pass over the single cutting well on the valve holder such that severing the first and second suture both releases tension in the anchoring stent and disconnects the valve holder from the prosthetic valve. 
     
     
       5. The system of  claim 4 , wherein the valve holder has three legs that contact the fabric-covered support structure at three locations, and wherein the second suture passes circumferentially around the valve holder and threads through the fabric at the three locations. 
     
     
       6. The system of  claim 5 , wherein the support structure has three commissure posts projecting in the outflow direction and three cusps therebetween that arc in the inflow direction, wherein the valve holder includes three legs that angle outward and in the inflow direction from the central hub to contact the prosthetic valve at the three cusps, and wherein the second suture is tied at first and second free ends to the holder, and in between passes circumferentially around the central hub of the holder and descends down each of the three legs to pass through two holes at a terminal foot thereof, the second suture being threaded through the fabric at each of the three cusps between the two holes, and wherein the second suture circles completely around each leg between the hub and the respective foot. 
     
     
       7. The system of  claim 1 , wherein the anchoring stent has a fabric covering, and wherein the at least one connecting suture passes through the fabric covering around the anchoring stent. 
     
     
       8. The system of  claim 1 , wherein the prosthetic valve has three commissure posts projecting in the outflow direction and three cusps therebetween that arc in the inflow direction, and the valve leaflets are flexible and partly supported by the commissure posts, wherein the valve holder includes three legs that angle outward and in the inflow direction from the central hub to contact the prosthetic valve at the three cusps, and wherein the at least one connecting suture is tied at two free ends to a terminal foot of one of the holder legs. 
     
     
       9. The system of  claim 1 , wherein the prosthetic valve has three fabric-covered commissure posts projecting in the outflow direction and three fabric-covered cusps therebetween that arc in the inflow direction, wherein the valve holder includes three legs that angle outward and in the inflow direction from the central hub to contact the prosthetic valve at the three fabric-covered cusps, and wherein the at least one connecting suture includes a first suture that extends around the anchoring stent and a second suture connecting the valve holder to the prosthetic valve that passes circumferentially around the valve holder and threads through the fabric at the three cusps. 
     
     
       10. The system of  claim 1 , wherein the at least one connecting suture consist of just first and second sutures, a first suture extending around the anchoring stent, wherein the anchoring stent has a fabric covering and the first suture passes through the fabric covering around the anchoring stent, and the second suture connects the valve holder to the prosthetic valve, wherein the prosthetic valve has a fabric-covering and the second suture passes through the fabric-covering of the prosthetic valve. 
     
     
       11. A method for delivering a prosthetic heart valve to a native valve annulus, comprising:
 providing a prosthetic heart valve including a prosthetic valve with valve leaflets mounted to alternately open and close across a flow orifice, and a self-expandable anchoring stent having a contracted state for delivery to an implant position and an expanded state, the prosthetic heart valve being connected to a valve holder with at least one connecting suture which extends around the anchoring stent in tension to constrict the anchoring stent to the contracted state, the at least one connecting suture being routed over a single cutting well on the valve holder; 
 attaching the valve holder to a delivery handle; 
 advancing the valve holder and connected prosthetic heart valve using the delivery handle to a native valve annulus; 
 severing the at least one connecting suture at the single cutting well to release the tension therein and permit the anchoring stent to expand toward its expanded state in contact with the native valve annulus. 
 
     
     
       12. The method of  claim 11 , wherein the prosthetic valve has a fabric-covered non-expandable, non-collapsible annular support structure defining the flow orifice and an inflow end defining an inflow direction with an outflow direction opposite thereto, the valve leaflets being attached to the support structure, and wherein the anchoring stent has a first end extending around the flow orifice connected to the prosthetic valve at the inflow end of the support structure, the anchoring stent having a second end projecting in the inflow direction away from the support structure, wherein the method includes transitioning the anchoring stent between conical contracted and expanded states. 
     
     
       13. The method of  claim 12 , wherein the at least one connecting suture includes a first suture extending around the second end of the anchoring stent which when placed under tension constricts the second end to the conical contracted state. 
     
     
       14. The method of  claim 13 , wherein the at least one connecting suture includes a second suture connecting the valve holder to the prosthetic valve, wherein the first and second sutures pass over the single cutting well on the valve holder such that severing the first and second suture both releases tension in the anchoring stent and disconnects the valve holder from the prosthetic valve. 
     
     
       15. The method of  claim 11 , wherein the prosthetic valve has three commissure posts projecting in the outflow direction and three cusps therebetween that arc in the inflow direction, and the valve leaflets are flexible and partly supported by the commissure posts, wherein the valve holder includes three legs that angle outward and in the inflow direction from the central hub to contact the prosthetic valve at the three cusps, and wherein the at least one connecting suture is tied at two free ends to a terminal foot of one of the holder legs. 
     
     
       16. The method of  claim 11 , wherein the prosthetic valve has three fabric-covered commissure posts projecting in the outflow direction and three fabric-covered cusps therebetween that arc in the inflow direction, wherein the valve holder includes three legs that angle outward and in the inflow direction from the central hub to contact the prosthetic valve at the three fabric-covered cusps, and wherein the at least one connecting suture includes a first suture that extends around the anchoring stent and a second suture connecting the valve holder to the prosthetic valve that passes circumferentially around the valve holder and threads through the fabric at the three cusps. 
     
     
       17. The method of  claim 11 , wherein the at least one connecting suture consist of just first and second sutures, a first suture extending around the anchoring stent, wherein the anchoring stent has a fabric covering and the first suture passes through the fabric covering around the anchoring stent, and the second suture connects the valve holder to the prosthetic valve, wherein the prosthetic valve has a fabric-covering and the second suture passes through the fabric-covering of the prosthetic valve. 
     
     
       18. The method of  claim 11 , wherein the prosthetic valve has a fabric-covered support structure and a compressible sealing ring surrounding the support structure, wherein the method includes seating the sealing ring against the native valve annulus. 
     
     
       19. The method of  claim 18 , wherein the support structure has an inflow end defining an inflow direction with an outflow direction opposite thereto, and wherein the anchoring stent has a first end connected to the prosthetic valve at the inflow end of the support structure and a second end projecting in the inflow direction away from the support structure, wherein the method includes advancing the anchoring stent through the native valve annulus, seating the sealing ring against the native valve annulus, and severing the at least one connecting suture to permit the anchoring stent to expand toward its expanded state in contact with the native valve annulus. 
     
     
       20. The method of  claim 19 , wherein the anchoring stent has a compressible sealing flange around the second end which contacts and seals against the native valve annulus.